**1. Introduction**

In the past few years, manufacturing processes involving chemical substances have evolved to a great extent, from the new technologies applied to these processes to the new products and materials produced and their regulatory framework. The chemical industry is at the heart of the European Union (EU) manufacturing industry, representing approximately 7% of EU industrial production and a 1.1%

share of EU GDP. It supplies two-thirds of its production to other sectors within the manufacturing industry [1].

In regard to the regulatory framework in the EU, two relatively-recent regulations stand out at first glance. Regulation (EC) No 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation), aims to protect human health and the environment by ensuring greater safety in the production and use of chemical substances. The REACH Regulation, which entered into force in 2007, applies to all chemical substances and thus has an impact on many businesses [2]. The classification and labelling of hazardous chemicals is governed by Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP Regulation). The CLP Regulation entered into force in 2009 and it enables identification of dangerous substances by means of classification and labelling, and informing users about their hazards through standard symbols and phrases [3].

In 2018, approximately 145,000 substances were classified according to the CLP Regulation [4]. Also in 2018, more than 21,000 substances were registered in the European Economic Area under the REACH Regulation, of which more than 12,000 are used in manufacturing processes. Figure 1 shows the evolution in the number of chemical substances registered in the European Economic Area under REACH [5] starting in January 2009, when records first exist, until August 2018. To this end, taking into account the uses and exposure to these substances, a distinction is made between their global life cycle and the life cycle applied to manufacturing.

**Figure 1.** Evolution in the number of chemical substances registered in the European Economic Area under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. January 2009–August 2018 [5].

This context of change generates both opportunities and challenges in many fields of knowledge. Among these fields, risk management is particularly important, both from a systemic point of view and from more specific perspectives. Among these specific perspectives, chemical risk management should be noted in order to prevent both occupational accidents and major accidents in manufacturing environments where hazardous materials are used. For this, two separate and solid legislative frameworks exist in the EU.

In the case of the risk management of occupational accidents, Directive 89/391/EEC on the introduction of measures to encourage improvements in occupational safety and health (OSH) should be pointed out [6]. This directive has been developed through a broad set of specific directives, with Directive 98/24/EC on OSH in the field of chemical agents [7] standing out in the context of hazardous materials.

In the case of the risk management of major accidents and hazards involving dangerous substances, Directive 2012/18/EU is applicable [8]. This directive states that its provisions should be applied without prejudice to the provisions of Union law relating to OSH and the working environment, and, in particular, without prejudice to Council Directive 89/391/EEC [6].

Hence, these risk management frameworks are closely related [9] and, as a result, are open to being studied from an integrative point of view. However, despite the importance of this relationship, scientific literature addresses the study of risk management of occupational accidents and major accidents involving dangerous materials in an independent and practically excluding manner.

In this regard, using the ScienceDirect database [10], the search for the keyword 'Directive 2012/18/EU' anywhere in an article, returns 13,584 papers. Similarly, the keyword 'Directive 89/391/EEC' returns 473 papers. However, combining both keywords with the AND operator returns three articles, which are: Rasmussen et al. [11], Besserman and Mentzer [12], and Li and Guldenmund [13].

This circumstance defines a closed border between these management systems, making it difficult to develop integrative techniques and methodologies that favour the reduction of risk due to hazardous substances. In addition to the described relationship between directives, the recent opportunity defined by the ISO 45001:2018 standard on OSH management systems [14] should be pointed out.

Thus, the main objective of this study is to identify and analyze the links and transitional spaces between the risk management of occupational accidents and major accidents involving hazardous materials. To achieve this goal, the methodology followed by this study is based on researching and carrying out a comparative analysis of the legal and standardised context described above. To this end, this work is organised as follows: (1) study of the legal context within the framework of the EU; (2) comparative analysis between management systems derived from Directive 89/391/EEC [6] and Directive 2012/18/EU [8]; (3) comparative analysis between management systems derived from the ISO 45001:2018 standard [14] and Directive 2012/18/EU [8]; (4) analysis of transitional spaces between risk management of hazardous materials in manufacturing processes; (5) discussion of results; and (6) conclusions.

#### **2. Legal Context in the European Union (EU)**

Directive 2012/18/EU (hereinafter, Directive Seveso III) is applicable in regard to the management of major accidents and hazards involving dangerous substances. This directive states that its provisions should be applied without prejudice to the provisions of Union law relating to OSH and the working environment, and, in particular, without prejudice to Council Directive 89/391/EEC.

The object of Directive 89/391/EEC (hereinafter, Framework Directive) is to introduce measures to encourage improvements in OSH. To this end, it contains general principles concerning the prevention of occupational risks, the protection of safety and health, the elimination of risk and accident factors, the informing, consultation, balanced participation in accordance with national laws and/or practices and training of workers and their representatives, as well as general guidelines for the implementation of said principles.

The Framework Directive serves as basis for more specific directives covering all the risks connected with safety and health in the workplace. Thus, 20 specific directives have been enacted to date since 1989, as listed in Table 1. Thus, Directive Seveso III is applicable to serious accidents and the Framework Directive to occupational risk prevention in a wide sense: that is, considering prevention of occupational accidents, illnesses and other dangers to the safety and health of workers.

Considering that the objectives of this study are linked to major accidents and occupational accidents, both concepts will be defined below. Then, the main relationships that exist between the directives involved in the legal context set out here will be analysed.


**Table 1.** Individual directives within the meaning of Article 16 (1) of Directive 89/391/EEC on occupational safety and health (OSH).

#### *2.1. Major Accident and Occupational Accident*

Directive Seveso III defines 'major accident' as an occurrence such as a major emission, fire, or explosion resulting from uncontrolled developments in the course of the operation of any establishment covered by this directive, and leading to serious danger to human health or the environment, immediate or delayed, inside or outside the establishment, and involving one or more dangerous substances.

The Framework Directive and its specific directives do not define occupational accidents. To this end, others sources are required. For example, Eurostat defines an occupational accident (or accident at work) as a discrete occurrence during the course of work which leads to physical or mental harm [34]. The ISO 45001:2018 standard defines 'incident' as an occurrence arising out of, or in the course of, work that could or does result in injury and ill health. An incident where injury and ill health occurs is sometimes referred to as an 'accident' [14].

Comparing the definitions for major accidents and occupational accidents, it could be said that a major accident could also be considered an occupational accident whenever there is harm to workers (injury and ill health). Among the specific directives developed following the Framework Directive, Directive 98/24/EC on chemical agents [7] is the one which, in principle, is more closely linked to Directive Seveso III. Taking this directive into account, it could be said that an occupational accident involving chemical substances is an occurrence arising out of, or in the course of, work that could or does result in injury and ill health for workers. All of this is regardless of the level of severity or seriousness of damage.

In any case, there are other directives besides Directive 98/24/EC on chemical agents [7] that are closely linked to Directive Seveso III. In order to identify these directives, the definition of major accident included in Directive Seveso III will be taken into account, considering to this end the occurrence of a major emission, fire, or explosion.

These events are covered by the industrial safety technologies (IST) studied by Sebastián and Brocal [35], which can be defined as follows: a set of instruments and industrial processes that enable the practical use in analysis, evaluation and control of specific risks being able to be classified into: work equipment; places and workplaces; handling, storage and transport; electricity; fires; and chemicals.

Sebastián and Brocal [35] studied the relationship that exists between IST and specific, applicable directives, the (adapted) results of which are included in Table 2. Considering this result, a preliminary approximation is then offered in regard to the technical–legal relationship that exists between the individual directives and Directive Seveso III.

**Table 2.** Industrial safety technologies (IST) linked to individual directives within the meaning of Article 16 (1) of Directive 89/391/EEC (adapted from [35]).


• Direct link. -Cross link.

### *2.2. Activity Involving Chemical Agents*

Directive 98/24/EC defines 'Chemical agent' [7] as any chemical element or compound, on its own or admixed, as it occurs in the natural state or as produced, used or released, including release as waste, by any work activity, whether or not produced intentionally and whether or not placed on the market. In addition, 'hazardous chemical agent' means: (a) any chemical agent which meets the criteria for classification as hazardous within any physical and/or health hazard classes laid down in the CLP Regulation, whether or not that chemical agent is classified under that regulation; (b) any chemical agent which, whilst not meeting the criteria for classification as hazardous in accordance with point (a) may, because of its physicochemical, chemical or toxicological properties and the way it is used or is present in the workplace, present a risk to the safety and health of workers, including any chemical agent that is assigned an occupational exposure limit value under Article 3 of this directive. Directive Seveso III defines 'dangerous substance' as a substance or mixture covered by Part 1 or listed in Part 2 of its Annex I, including in the form of a raw material, product, by-product, residue or intermediate.

The main difference observed on comparing the definitions of 'dangerous substance' (Seveso III) and 'hazardous chemical agent' (Directive 98/24/EC [7]), lies in the former referencing specific substances and amounts (Annex I) while the latter has a much broader and general definition, considering any substance that could give rise to an occupational risk, regardless of whether they meet the classification criteria laid down in the CLP Regulation [3].

Thus, Directive 98/24/EC [7] will be applicable to any work with dangerous substances according to Seveso III, given that these dangerous substances will also be hazardous chemical agents.

Additionally, Directive 98/24/EC defines 'Activity involving chemical agents' as any work in which chemical agents are used, or are intended to be used, in any process, including production, handling, storage, transport or disposal and treatment, or which result from such work [7]. Directive Seveso III defines 'presence of dangerous substances' as the actual or anticipated presence of dangerous substances in the establishment, or of dangerous substances which it is reasonable to foresee may be generated during loss of control of the processes, including storage activities, in any installation within the establishment, in quantities equal to or exceeding the qualifying quantities set out in Part 1 or Part 2 of its Annex I.

The main difference observed in regard to criteria regarding the presence of dangerous substances again lies in the variables collected in Annex I of Directive Seveso III. Thus, Directive 98/24/EC [7] will be applicable to any occupational activity involving dangerous substances included in Seveso III.

Directive 98/24/EC on chemical agents [7] is complemented by Directive 2004/37/EC on carcinogens or mutagens at work [20], as collected in Table 2. The CLP Regulation [3] may be considered the connection point between both directives. Similarly, this regulation is also linked closely to Directive Seveso III.

With the aim of establishing these links, Table 3 collects 7 dangerous substances. These 7 substances have been selected as follows: (a) of the 48 substances collected in Annex I, Part 2 of Seveso III, those with a CAS number have been selected, amounting to 35; (b) for each of these 35 substances with a CAS number, the INFOCARQUIM database [36] has been used to determine those which are carcinogens or mutagens (1A/1B) according to the CLP Regulation; (c) from the 35 substances above, 7 substances have been identified as carcinogens or mutagens; (d) for each of these 7 substances, their H statements have been identified with examples of manufacturing processes, also by using the INFOCARQUIM database; (e) for the 7 substances above, their threshold limit values (VLA, *Valor Límite Ambiental*) have been identified according to the document on the limits of chemical agents for professional exposure in Spain [37].

VLA are reference values for chemical agent concentration in the air and represent the conditions for which it is believed that, based on current knowledge, most workers may be exposed to on a daily basis throughout their work life without suffering adverse effects on their health [37].

Thus, the 7 substances mentioned will be subject to the implementation of Directive Seveso III according to the figure collected in columns 2 and 3. Additionally, these substances fall within the scope of Directive 98/24/EC [7] and Directive 2004/37/EC [6] whenever they are found in workplaces. When these substances may be inhaled by workers, applicable threshold limit values must be considered. For Spain, these values are collected in Table 3.

Although not contained in Table 3, the applicability of other directives and regulations should be analysed for every manufacturing process that is studied; for instance, the directives collected in Table 1. To this end, one of the essential sources of information is the H statement collected in Table 3.

